ResearchMaster

Human Ethics Application

Application ID : 0000015061Application Title : Marital Status and cognitive decline in an ageing population: Does Bereavement of a partner make a difference? (Social Support

and lifestyle as mediators of healthy ageing. )Date of Submission : 02/02/2015Primary Investigator :Other Investigators :

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Ethics category*

Human

Application (Project) Title*

Marital Status and cognitive decline in an ageing population: Does Bereavement of a partner make a difference? (Social Support and lifestyle asmediators of healthy ageing. )

What is Faculty, Centre, Unit or Office of the Primary, or Chief Investigator for this project?*

School of Humanities and Social Sciences

Please indicate the Faculty or Institute which is supporting this research.*

Business

Health Sciences and Medicine

Law

Society and Design

Not Applicable

Choose the best option to describe the purpose of this ethics clearance

1 Research

Do any of the following apply to this research?

This is a Higher Degree Research Project

This is <i>Other</i> student research (<i>i.e.</i> research by non­HDR student/s)

This is Faculty research conducted by member/s of academic staff

This is non­Faculty research conducted by members of staff

This is a research project conducted by an external organisation or individual

What mode of data collection will be used?*

Question­asking/Survey

Anticipated start date for data collection (DD/MM/YY)*

30/11/2014

Anticipated finish date for your project (DD/MM/YY)*

30/12/2018

Is it intended that the results of the study be published?*

Yes No

Where are the results are likely to be published?

Conference presentation.

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Introduction

Administrative Section

Title and summary of Project

Co­Researchers

Bond Staff and many Bond students will be searchable in the lookup table below. Some researchers from other institutions will also appear, please search forexternal researchers and if they do not appear, you have the option of adding them to the system using the 'add new researcher' icon at the top right of the returnscreen. Please ensure that any new researcher you create in the system has an email address so that we can contact them.

If you select a person already in the database and they have no email address, please notify the Research Ethics Manager advising the application ID, the person`sname and their email address.

If your Co­Researcher is a student at Bond University and their name does not appear in the lookup below, please contact the Research Ethics Manager byemail or call on 07 5595 4194 and we will add their details to the research management system immediately. This is a very quick process and will not hold up yourapplication.

List all researchers involved in this project.

1 Given Name

Middle Name

Surname

Preferred Full Name

Primary contact? Yes

Position Chief Investigator

Person Category Internal

Email Address

Supervisor System Code

Business Unit (School or Department) SFSDHUMSS

Organisation Name

2 Given Name

Middle Name

Surname

Preferred Full Name

Primary contact? No

Position Chief Investigator

Person Category Both

Email Address

Supervisor System Code

Business Unit (School or Department) SFSDHUMSS

All researchers will be required to sign off on this form in the 'Documents and Declarations' section.

Having trouble with any of this? Call the Research Ethics Manager on (07) 5595 4194 or email.

Project Funding & Sponsorship

Is this a funded research project?*

Yes No

Specify the other source.*

Not funded. Masters research project

Does the project have any sponsors or partners apart from funding bodies?*

Yes No

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Reviews undertaken by external Human Research Ethics Committees (HRECs)

Can your project be reviewed by Bond University's HREC on its own, or will other HRECs need to be involved? *

Yes ­ BUHREC is the only Committee with jurisdiction

No ­ other HREC(s) will have to authorise the project before it can proceed

I don't know ­ step­by­step help follows

Do you intend to submit a National Ethics Application Form (NEAF) (or any other non-BUHREC ethis application form) for review by BUHREC?*

Yes

No

Research Design

Tell us about your research

This research involves:*

Qualitative measures

Quantitative methods, population level data or databanks

Theoretical Rationale Write a concise, jargon­free explanation about this research. Link your project to a problem or theory identified in the relevant literature. If appropriate, state yourhypotheses. (Form limits length to 4000 characters, approx 650 words).*

The experience of decline in an individual’s level of cognitive functioning is common during the later years of life, having a profound impact on anindividual’s health and wellbeing (Centers for Disease Control and Prevention, 2014). Research has identified a number of risk factors associatedwith cognitive decline such as depression, cardiovascular disease, nutrition, physical fitness, and education (Deary et al., 2009; Oknonkwo et al.,2010; Rosenblatt, Mehta, Romanoski, Eaton, & Lyketsos, 2003). The death of a spouse and bereavement are also risk factors, as older adultsexperiencing bereavement and widowhood were found to perform more poorly on measures of cognitive functioning than non­bereaved andmarried individuals (Aartsen, Van Tilburg, Smits, Comijs, & Knipscheer, 2005; Ward, Mathias, & Hitchings, 2007). Nihtila and Martikainen (2008)found in their study that the risk of institutionalisation was greater among older adults who lost their spouse compared to those still living withtheir spouses, particularly during the first month of death. As spousal death has been found to have a significant effect on cognitive decline, thepresent study will expand on research by investigating the impact of individuals martial statuses on cognitive impairment and also identify areas ofresilience preventing a decline of cognitive functioning in the aged population.

Please tell us your key references. (Form limits length to 2000 characters, approx 300 words).*

Aartsen, M. J., Van Tilburg, T., Smits, C. H. M., Comijs, H. C., & Knipscheer, K. C. P. M. (2005). Does widowhood affect memory performance ofolder persons?. Psychological Medicine, 35, 217­226. doi: 10.1017/S0033291704002831 Centre for Disease Control and Prevention. (2014). Healthy brain initiative. Retrieved from http://www.cdc.gov/aging/healthybrain/ Deary, I. J., Corley, J., Gow, A. J., Harris, S. E., Houlihan, L. M., Marioni, R. E., Penke, L., Rafnsson, S. B., & Starr, J. M. (2009). Age­associatedcognitive decline. British Medical Bulletin, 92, 135­152. doi:10.1093/bmb/ldp033 Nihtila, E., & Martikainen, P. (2008). Institutionalisation of older adults after the death of a spouse. American Journal of Public Health, 98, 1228­1234. doi: 10.2105/AJPH.2007.119271 Okonkwo, O. C., Cohen, R. A., Gunstad, J., Tremont, G., Alosco, M. L., & Poppas, A. (2010). Longitudinal trajectories of cognitive decline amongolder adults with cardiovascular disease. Cerebrovascular diseases, 30, 362­373. doi:10.1159/000319564 Rosenblatt, A., Mehta, L. M., romanoski, A., Eaton, W., & Lyketsos, C. (2003). Major Depression and cognitive decline after 11.5 years: findingsfrom the ECA study. The Journal of Nervous and Mental Disease, 191, 827­830. doi: http://dx.doi.org/10.1097/01.nmd.0000100927.83451.63 Ward, L., Mathias, J. L., & Hitchings, S. E. (2007). Relationships between bereavement and cognitive functioning in older adults. Gerontology,53, 362­372. doi: 10.1159/000104787 Piper,B.J., Yasen, A.L. & Miller, J.K. (2011) Examination of Sexually Dimorphic Behavior on the Novel­Image Novel­Location Recognition MemoryTest, Journal of Behavioral and Brain Science, 1, 134­139 doi:10.4236/jbbs.2011.13018 Published Online August 2011 (http://www.SciRP.org/journal/jbbs)

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Description of Participants

Approximately how many participants are involved in your study?*

100.00

What kinds and ages of people will these be? (e.g. school children age 6­9 who have epilepsy). Describe any subgroups here (e.g. treatment vs. control groups) and saywhat the n will be for each subgroup.*

Mature adults 50+ years of age with no known mental or physical impairments living in the community. Previous studies have shown that earlysigns of cognitive decline may be evident in community living healthy adults from middle age.

Is this research a repeat use of participants?*

Yes No

Tell us about Recruitment

How will participants be recruited? (Form limits length to 4000 characters, approximately 650 words)*

Participants, will be recruited from the general community using the sampling frame of the previously approved projects RO934 & RO934A. Community samples will be recruited by convenience sampling. Onceapproached, the nature of the study will be explained to participants and they will be asked to read the explanatory statement. Informedconsent will be obtained and the participant’s rights will be explained to them before seeking written consent. They will be asked to complete abattery of tests presented on a tablet computer, or an equivalent pen and paper instrument if they express difficulty in operating a tabletcomputer. Mode of response will be recorded and analysed as a potential confound during the analysis stage. To avoid response bias theexplanatory statement and consent form will use the less confronting alternate title (Social Support and lifestyle as mediators of healthy ageing )rather than the thesis title. This title is likely to be more appropriate for the majority of participants who will not have encountered partnerbereavement.

Where will participants be recruited? (Form limits length to 4000 characters, approximately 650 words)*

The sample will be recruited in public spaces accessible to the general community where gatekeeper permission will not need to be sought (inshopping precincts but not in the commercial spaces, curbside and door knock recruitment). This is consistent with the recruitment strategyused in prior approvals (RO934 & RO934A). Public space recruitment is used to avoid inconvenience to commercial operators. The researcher willbe accompanied by a chaperone for recruitment to mitigate any risk of unwanted attention. As its unlikely that participants will wish to completethe instrument standing they will be invited to be seated to complete the instrument or make an appointment to return to complete theinstrument at a convenient coffee shop.

Who will recruit the participants? (Form limits length to 4000 characters, approximately 650 words)*

Research will be undertaken by the student researcher Jessica Carroll.

How and by whom will the research purpose and process be explained to the participants? (Form limits length to 4000 characters, approximately 650 words)*

The research purpose and process will be explained to the participants as described above.

How will potential participants indicate their agreement to participate in the research? (Form limits length to 4000 characters, approximately 650 words)*

Written consent will be obtained prior to collecting data.

A Participant Information Sheet (Explanatory Statement) should be given to participants who are actively taking part in a research project; please attach your ParticipantInformation Sheet/Explanatory Statement to this application.

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If it makes sense to do so, please give a rationale for the sample size adopted

Description Reference Soft copy Hard copy

Explanatory Statement PIS.pdf

Participant Consent Form consent.pdf

Survey, Questionnaire or Interview Script revised About You.pdf

Advertisement Documentation NINLRB.pptx

Methodology

Tell us what you will do with your participants from the start to the end of the study, including:

1. How much time you are asking of each participant2. If there are treatment and control groups, explain what happens to each3. If tests, surveys, or interviews will be used, describe them

(Form limits length to 2000 characters, approximately 350 words).*

1. Participants will be verbally briefed as to the purpose of the study and asked to complete a series of pen and paper instruments listed in 3.Below. This will include demographic details including marital status, highest education level and SES measures which are anticipated to predictchanges in outcome for cognitive decline.

2. This is a regression design (including dummy coded variables) as such their is no control group although some aspects of analysis will allow thedirect comparison of groups. To that extent the study is a natural experiment taking advantage of the distribution of events in the population. Ifmore time was available a more targeted direct sampling approach would be adopted but given the time frame of the Masters thesis theapproach adopted is likely to be more feasible.

3. Measures:The NINL (Rizk­Jackson, 2006) is an object recognition test designed to assess cognition and detect risk factors for developing age­relatedcognitive decline in non­demented elderly. The test involves the participants to memorise a number of panels of four quadrants, with three outof the four containing different images and the positioning of the images varying in three of the four quadrants. The participant is presentedwith the first set of 12 panels. Immediately following this is a second set of 12 panels is presented with either the same images (no change), adiffering novel image, or the location of an image moved to an empty quadrant. After 5 minutes the participant is presented with a third panelwith similar or differing images and location. The Participant is required to correctly identify whether there was a change, and if so, how thepanel changed (image or location), and the location of the change (which quadrant).

Please see the rest of the measure descriptions in the comments

Tell us how you plan to analyse the data you will collect. If relevant, briefly discuss the statistical tests you will use and why you will use them. (Form limits length to 4000characters, approximately 650 words).*

The primary method of analysis will be by Hierarchical Multiple Regression to maximize power from a likely small sample. G*Power indicates that asample of 43 is adequate if the effect size is large (our expectation) and conventional alpha = .05 with a liberal power of .80 is targeted and with5 predictors, with oversampling our minimal target sample is 60. If the effect size is moderate we will need 100 participants.

Please describe the research location. (Form limits length to 2000 characters, approximately 350 words).*

Community samples will be recruited by convenience sampling in public locations such as Cavill mall, where gatekeeper consent is not required.

Please provide names, addresses and contact details of all sites where research will be conducted. (Form limits length to 1500 characters, approximately 200 words).

Not applicable

Will you be photographing or recording audio or video of the participants? *

Yes No

If tests, surveys or interviews will be used, attach a copy of the questions to the document list below.

You can also attach copies of permissions from venues here.

Description Reference Softcopy

Hardcopy

Explanatory Statement PIS.pdf

Participant Consent Form consent.pdf

Survey, Questionnaire or Interview Script revised About You.pdf

Advertisement Documentation NINLRB.pptx

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Data Management

Bond University's Code of Conduct for Research Policy (TLR5.06) provides general principles and important details on the management of research data. You havea responsibility to ensure your research activities adhere to the principles contained in this policy.

In brief, research data and records must be safely stored and maintained to prevent unauthorised access, destruction, alteration or removal, accidental orintended damage or destruction. Confidential research data and records must be stored securely.

Data must be retained for a sufficient time to allow for reference. It is recommended that the minimum period for retention is at least five years from the dateof publication but for specific types of research, such as clinical research, data should be kept for fifteen years. The potential value of data and material for furtherresearch should also be considered, particularly where the research would be difficult or impossible to repeat. (See the Queensland State Archives Universitysector retention and disposal guide for additional guidance).

Access to research data should be considered in the context of ethical, privacy, confidentiality, cultural and intellectual property and funder requirements andunder the Guidelines to the Australian Privacy Principles*. Research data from publicly funded research projects (such as by the ARC or the NHMRC) must beplaced into an appropriate repository, usually within twelve months of publication. When using or re­using research data made available by other researchers, BondUniversity researchers must comply with copyright, moral rights and licence requirements.

See the Research Data Management Toolkit for more information.

*Nb. The Australian Privacy Principles replaced the National Privacy Principles in March 2014.

Have you completed a Research Data Management Plan? *

Yes No

Where will the data be stored during the study?*

The data will be stored as an electronic file in the PI's and CI's offices.

Where will the data be stored following the completion of the study? What security measures will you take to protect it? (Form limits response to 1500 characters,approximately 250 words).*

A complete data set will be stored for a minimum of 5 years in accordance with the requirements of the National Statement(2007) in regards topreservation of data. After 5 years a decision will be made as to the further preservation of the data depending on publication status. If the datahas no further value it will be destroyed by deletion. The office is secured by lock and key and the computer the data is stored on is passwordprotected.

Please describe your data sharing, retention and disposal plans. (What will you share, how will it be shared, what will be destroyed, when and how?). (Form limits responseto 1500 characters, approximately 250 words).*

As no personally identifying data is to be collected the data will be anonymous. As such it has the potential to be shared in a public repository,however we have no current intent of storing it in a public repository. If on publication interest is generated we would be willing to release thedata for public use.

Will the confidentiality of participants and their data be protected in the dissemination of research results?*

Yes No

Explain how confidentiality of participants and their data will be protected in the dissemination of results. (Form limits response to 4000 characters, approximately 650words).*

Whilst detailed demographics are collected from participants participants do not identify themselves on the instrument and even in the event ofcoincidental recruitment of an individual known to the participant once the data is collected online it is not traceable back to a particularindividual. To ease processing and ensure a standard data entry format, and instrument completed in pen and paper form will be hand coded intothe electronic form. As such the origin of a particular case in the dataset will not be knowable to the researcher. In reporting data only group oraggregated data will be reported as such confidentiality of data is guaranteed.

Do you intend to give feed back to participants about their own results?*

Yes No

Do you intend to report general (non­specific) results of the research to participants, or to debrief them in any way?*

Yes No

Do you intend to report results that relate to a specific participant to anyone other than that participant?*

Yes No

Are you, the researcher(s), required by law to report any of the findings (e.g. some infectious diseases, suspected child abuse, etc.?*

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Do you have a contingency plan for the storage and secure disposal of data should members of hte project team (including the CI) leave the institution? Who would retain the data and if appropriate be responsible for timeple and secure disposal?

Yes No

Risk Assessment

Interventions and tests

Identification of potential risks is the first step in good ethics practice. In this section of the form on Risk Assessment, please consider carefully whether any of therisks listed are or have the potential to be associated with your research project. You will be provided with an opportunity to provide an assessment of theirlikelihood, to show how the risks may be justified in the context of your research proposal, and what strategies you will take to mitigate them. (The Committeemay, if it thinks appropriate, propose alternative strategies as part of the review process).

Clinical Trials

Bond University operates a definition of 'clinical trial' for insurance purposes. The following question(s) in this section will establish whether you require Medical MalpracticeInsurance. (Note that this does not necessarily mean that your project will need additional review under Therapeutic Goods Administration (TGA) guidelines).

Will your research investigate whether an intervention leads to an improved health outcome?*

Yes No

Other interventions

Will the research involve the administration of ANY tests or procedures that can only be used by people with certain qualifications or training? (This may include, e.g.,clinical procedures, administration of psychology survey tools, etc.)

Yes No

Is there any risk of physical/psychological stress, inconvenience or discomfort beyond the normal experience of everyday life, in either the short or long term, fromparticipation in this project?*

Yes No

Please explain the nature of this risk including its duration and severity. (Form limits response to 4000 characters, approx 650 words)

The rationale for the study is based upon the notion that social support forms a mediating factor in the preservation of function in a healthyaging adult. Consequently an ageing adult who becomes socially isolated by change of circumstances including but not limited to thebereavement of a spouse is likely to be at risk of decline beyond that of an adult with a strong ongoing support network. It is likely that someparticipants in our study will have lost a partner, or loved one or because of changes in circumstances moved away from an existing social supportnetwork. These participants will be more at risk than those who have not yet experienced those events. The sad reality however is that we allexperience this type of event across the course of a lifetime and it may be argued then that the study does not elevate risk above baseline forthe community. Never the less, the researcher is sensitive to the possibility that some participants may have grief or loneliness as a consequence,and indeed to some extent this is desirable in the study.

Please say what you will do to minimise or alleviate this risk to participants. Are there reasonable steps you could take to reduce its likelihood ? (Form limits response to 4000 characters, approx 650 words)

The researcher will at the time of recruitment outline the purpose of the study and indicate the sorts of life changes that might influencehealthy ageing and mediate against cognitive decline this will include changes in social life and the death of a partner. Participants will bereassured that we are interested in all participants in the age group not simply those who have a recent bereavement. In the event that thislevel of discussion elicits stress the participant will be asked if they need assistance and be provided with Lifeline and Relationships Australiacontact details if necessary. If participants wish to participate but have shown signs of distress they will be given a contact number and a coolingoff period to avoid any duress to participate. If participants are not distressed at the outset they will be invited to participate in the study andtheir state will be discretely monitored by the researcher during completion of the instrument.

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Please say what you will do should participants experience such stress, inconvenience or discomfort during the research. Are there counselling or other resources you will you refer them to? (These risks should normally be outlined in the Explanatory Statement and Consent Form. In such cases it is often advisable to make available the telephone counselling number for Lifeline and similar agencies in the Explanatory Statement).(Form limits response to 4000 characters, approx 650 words)

In the unlikely event that this level of discussion elicits moderate or severe stress the participant will be asked if they need assistance and beprovided with Lifeline and Relationships Australia contact details if necessary. The researcher will not attempt to provide primary counsellingservices in the test environment, as this is unlikely to be effective or useful and might actually worsen any level of stress.

Vulnerable Participants

Is there a potential for power­dependency between researcher/data collection personnel and participants? (E.g. are any of the researchers intending to use their ownstudents, patients, clients etc?)*

Yes No

Will participants be deceived about the nature of the research? *

Yes No

Please explain why the real nature or purpose of the research needs to be concealed. (Form limits response to 2000 characters, approx 350 words)*

There is no real deception involved here but the thesis title features the term bereavement, and it investigates (if possible from the obtaineddata) the influence of changes in social support in an aged population impacts upon their cognitive health and well­being. However, the questionis being examined more broadly than is implied by bereavement as the sample of bereaved partners is problematic to sample. If the literature iscorrect bereavement is associated with some degree of public withdrawal and it is not immediately obvious where to sample from to obtain asample of older people with recently bereaved partners. The obvious choices may be associated with recent and intense grief which wouldcolour the results so a community sample is chosen with a broader sampling frame with the intent of finding older people in the community whodue to changes in circumstances such as bereavement or "sea­change" decisions have changed their social support networks. There is also aconcern that using the term bereavement in a consent form may cause self­censoring of participants.

Does this research involve or target any of the following: minors; people under institutional care (prisons, hospitals, wards of state etc); specific ethnic groups; people in another country; or any other special groups who may be more vulnerable than the general population?*

Yes No

Will you need to take any participants alone to a private place to conduct the research?*

Yes No

Potential Conflicts of Interest

Are any of the researchers intending to undertake research in an area where they have a financial or commercial interest?*

Yes No

Will there be any incentive, payment or reimbursement offered to participants?*

Yes No

Consent

Will participants be asked to give consent?*

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Yes No

What form will consent take?*

Signed participant informed consent form

Consent is implied by participation

Other (please ensure you have given a detailed response to the question about consent below)

Your answer to an earlier question about participant consent is reproduced below for ease of review. (You may update your answer if you wish. Any changes you makehere will update your answer in the Research Design section, on the page Tell us about Recruitment).

How will potential participants indicate their agreement to participate in the research?

Written consent will be obtained prior to collecting data.

Is gatekeeper permission required from any organisation(s) that may control access to participants?*

Yes No

If you have a Participant Consent Form, or a special Consent Form for research with minors, collectives or special groups please attach it below.

If you require Gatekeeper Approval, you must provide BUHREC with written Gatekeeper/Authority Approval before this application will be granted ethics clearance. Shouldyou require ethics approval before you can get approval from gatekeepers, or if that approval is pending, please make sure you let us know.

Description Reference Soft copy Hard copy

Explanatory Statement PIS.pdf

Participant Consent Form consent.pdf

Survey, Questionnaire or Interview Script revised About You.pdf

Advertisement Documentation NINLRB.pptx

Confidentiality

Will participants' identity be known in any way to you, the researcher(s) or to other participants?*

Yes No

Will participants' private records be accessed for this research, or will you use existing records or data that is not ordinarily available to the public (e.g. medical records,personal diaries, student files, computer records or other data banks not available in a public library?)*

Yes No

Have you identified any other risks to the confidentiality of personal information not already considered?*

Yes No

Are you aware of any other privacy issues that may impact on participants?*

Yes No

Benefits & Risks

Level of Risk

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In order for the logic of this section of the form to work correctly, it is important that you have:

1. completed the earlier sections of the application; and that2. you answer the questions on this page in order.

Please do not attempt this page until you are satisfied with your answers on the previous sections (especially Research Design and Risk Assessment). Once youhave responded to the questions on this page any subsequent changes to questions in earlier sections of the form may render the risk calculation on this pageinvalid.

Have you completed the earlier sections of this form (is each page ticked)?*

OK, I am ready to proceed

The need or intention to engage in any of the practices listed below indicate some degree of risk associated with your project. It should be noted, however, that inthe right context, many of them comprise good research practice, and should not be avoided for the purposes of reducing the appearance of adding risk.

Your answers to questions on the areas listed below indicate that your project entails a degree of risk to participants. Overall this risk may be very small or very large. Therisks identified may be addressed by the protocols you have in place to mitigate their effects.

Increased physical or psychological risk

Deception of participants

In the following space, please weigh the potential benefits of your project (to participants, to the academic or wider community) against the potential risks identified. (Formlimits response to 2000 characters, approx 300 words)*

In drawing a sample of mature adults from the general community there is a risk that at least some of those participants will have experiencedthe loss of a significant other at some time in the past. As a background risk the loss of a family member for an adult participant must approachunity. In a broad sense everyone has lost someone. This study investigates the effect of the relatively recent loss of a partner by eitherbereavement or separation on the mental state and cognitive function of mature adults to determine the if as the literature claims this type ofevent appears to be associated with lower function than those with intact relationships, the study will provide some insight into other lifestylefactors which might mitigate the harm cause by such an event. Given the relatively good health of the Australian population and the tendencyfor the recently bereaved to isolate themselves a threat to the design but also a mitigator of risk is that the likelihood of chance encounter witha very recent bereavement is small. In the event of such an encounter the researcher can provide a referral to an aid service that wouldotherwise be unavailable.

This application will be forwarded for review by the Full Panel.*

I concur

Documents & Declarations

Attachments

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Please review the documents you have so far attached to this application. You can update new versions, or attach any that are missing on this page.

Templates for Attachments and Forms:

Participant Information Sheet (Explanatory Statement) Request Gatekeeper/Authority ApprovalIf the Bond University templates above done quite fit the bill, try the NHMRC's Standardised Participant Information and Consent forms

Attached Documents

Description Reference Softcopy

Hardcopy

Explanatory Statement PIS.pdf

Participant Consent Form consent.pdf

Survey, Questionnaire or Interview Script revised About You.pdf

Advertisement Documentation NINLRB.pptx

Declaration

This declaration must be signed off by all members of the Research Team listed in this application. The points in this declaration are mainly drawn from theNHMRC's National Statement on Ethical Conduct in Research Involving Humans. Please ensure that you have read and agreed with each paragraph ofthe statement below.

Responsibility for the conduct of this research rests with the applicant(s).

If any changes to the protocol are proposed after the approval of the Committee has been obtained, then BUHREC will be informed immediately of any matter that maywarrant review of ethical approval of the protocol, including:

(a) serious or unexpected adverse effects on participants;(b) proposed changes in the protocol; or(c) unforeseen events or adverse occurrences that might affect continued ethical acceptability of the project.

If BUHREC imposes any conditions upon their approval of this research, the research can only proceed after such conditions have been satisfied and after notification ofcompliance with such conditions has been made to BUHREC.

Where BUHREC is satisfied that circumstances have arisen such that a research project is not being or cannot be conducted in accordance with the approved protocol andthat, as a result, the welfare and rights of participants are not or will not be protected, BUHREC may withdraw approval. This research must not continue if ethical approvalis withdrawn.

In the preparation for and conduct of this research, the researcher(s) shall give every respect and consideration to participants’ rights, beliefs, perceptions, customs andcultural heritage both individual and collective.

At least annually (and more often if specified by BUHREC), reports must be submitted from Principal Researchers on matters including: progress to date or outcome in thecase of completed research; secure maintenance of records; and compliance with any conditions of approval.

BUHREC may recommend and/or adopt any additional appropriate mechanism for monitoring this research, including random inspections of the data, research sites andsigned consent forms, and/or interviews of research participants (with prior consent).

The National Health and Medical Research Council (NHMRC) may, from time to time conduct audits through the Australian Health Ethics Committee to ensure compliancewith this declaration and statement contained in this questionnaire.

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1 Full Name

Position Chief Investigator

Declaration Signed? Yes

Signoff Date 07/10/2014

2 Full Name

Position Chief Investigator

Declaration Signed? Yes

Signoff Date 16/12/2014

Submission Instructions and what happens next

Is your application complete and ready to go? You have two options: either request a review from a peer or colleague at Bond University, or submit your application directlyto the formal review process.

1. To request a colleague to do a Peer Review before submission, go to the Review tab in the middle of the panel on the left. Click on Peer Reviewerand type the name of your reviewer into the search box. BEWARE ­ it is possible to send an application to Peer Review without specifying a reviewer. If thisoccurs the system allows you to recall the application from Peer Review and try again (this option is available from the Action tab).

You may nominate several reviewers at once, but once you have submitted the application for Peer Review you will not be able to access the Review tab tonominate further Peer Reviewers, unless you subsequently recall the application from Peer Review. Consider your choice carefully.

Once you have made a choice of Reviewer(s), (you may also think it worth assigning a date by which they should complete their review) click on the Actiontab to choose Send to Peer Review.

We strongly suggest you contact your Peer Reviewer(s) yourself first to ensure that they are willing and able to look at your application. Peer Reviewershave the option of declining a request to review, but until they do so online the option to forward to a second choice will be unavailable to you, until yourecall the application from Peer Review.

PLEASE NOTE: Anyone on your list of co­researchers will automatically have access to the form; for students, this should include your supervisor. If youwant to get them involved in completing the form, you can notify them by using the 'Invite research colleagues to sign off' Action (see below).

2. Have all your co­researchers signed off on the application? If not, click on the Action tab and choose Invite colleagues to sign off. You shouldnot formally submit your application until all researchers have signed off. You must name all members of the research team in your submission.

If one of your colleagues is unable to log in and sign off, please contact the Research Ethics Manager early (tel. 07 5595 4194).

3. To submit your application for Formal Review click on the Action tab and choose Submit for Formal Review. If you are an academic member of staffor a student, your application will go first to your Faculty or Institute for their approval. If everything is satisfactory, your Faculty Research Committee willauthorise your application and submit it to BUHREC. Arrangements will differ slightly from Faculty to Faculty, but in general we would advise you to allow upto a week for Faculty to approve applications.

If you are not a member of a Faculty or Institute (i.e. if you are an External Applicant, or you are a Bond staff member of the library, marketing or othersupport office), your application will come directly to the BUHREC office for allocating to the next available Committee Meeting.

Please refer to BUHREC's Submission deadlines and Meeting Dates and ensure you leave sufficient time for your application to meet the BUHREC submissiondeadlines. Remember to leave sufficient time for Faculty Review ahead of BUHREC's submission deadlines.

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The review process, amendments and approvals

If your Peer Reviewer or your Faculty Research Committee have comments or request amendments, you will be notified by system­generated email and theircomments will appear within your application as flagged pages, or a flag next to the application title. You must respond either by making the requestedamendments or by adding your own commentary, then clicking on the Action tab and choosing Resubmit. This will trigger an email alert to the Reviewer thatyour responses are available to view, and they must approve your amendments (or your response), before the application is released back to you or to the nextstep in the submission workflow.

A similar process of review, request for further clarification or amendment may occur as part of the Ethics Committee review. You will receive system­generatedemail alerts when Peer and Faculty reviews are complete; upon formal submission of your application to BUHREC; if there are queries from the Ethics Committee;and when approval has been granted.

The application process thus goes from you, the Applicant > Peer Reviewer (if requested) > Applicant > Faculty Review > BUHREC Review > Applicant statingoutcome (with possible detours back to the applicant at each stage if amendments are requested). A somewhat abbreviated process bypassing Faculty Reviewexists for external applicants and Bond general staff.

IF YOU ARE USING AN OLDER VERSION OF INTERNET EXPLORER AND THE TEXT IN THE REVIEW OR ACTION TAGS DISAPPEARS, YOU MAY HAVE TO TURN ONCOMPATIBILITY VIEW. YOU WILL FIND THIS AS AN OPTION IN THE TOOLS MENU.

Having trouble with any of this? Call the Research Ethics Manager on (07) 5595 4194 or email.

If you have any questions or comments about this form or the online ethics process, please email or call the Ethics Manager, or leave a comment here.

This question is not answered.

This form is COMMERCIAL IN CONFIDENCE

Office Use Only

Office Use Only

Application ID

0000015061

Application Title

Marital Status and cognitive decline in an ageing population: Does Bereavement of a partner make a difference? (Social Support and lifestyle asmediators of healthy ageing. )

Primary Contact

Dr Mark Peter Bahr

Application Date

02/02/2015

Reviewing Committee

2. BUHREC Sub­Committee

Meeting no.

S03/14

This application is for Full review.

Review type

This question is not answered.

Reviewers

This question is not answered.

Identified risks (copy text from Level of Risk page)

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